Submissions for Postapproval Modifications to a Combination Product Approved Under a BLA, NDA, or PMA
This document provides guidance to industry and FDA staff on the underlying principles to determine the type of marketing submission that may be required for postapproval changes to a combination product, as defined in 21 CFR 3.2(e), that is approved under one marketing application, i.e., a biologics license application (BLA), a new drug application (NDA), or a device premarket approval application (PMA).
This guidance supplements existing guidance documents developed by the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research (CDER), and the Office of Combination Products (OCP).
This guidance does not address changes to combination products that are not approved under a BLA, NDA or PMA (e.g., those cleared solely under a device premarket notification submission or those marketed under an over-the-counter drug monograph). Nor does this guidance address changes to combination products that were approved under more than one marketing application. Further, while this guidance does address the type of submission to provide when making a change to a constituent part of a combination product approved under one marketing application, it does not address the scientific or technical content to provide in any such submission.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.